The Youth Opioid Recovery Support (YORS) Intervention: An assertive community treatment model for improving medication adherence in young adults with opioid use disorder

青年阿片类药物康复支持 (YORS) 干预：一种自信的社区治疗模式，用于改善患有阿片类药物使用障碍的年轻人的药物依从性

• 批准号: 10467167
• 负责人: MARC FISHMAN
• 金额: $ 246.57万
• 依托单位: MARYLAND TREATMENT CENTERS, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-28 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10467167
• 关键词: Acute; Address; Adherence; Affect; Age; Assertiveness; Attitude; Back; Baltimore; Behavior; Behavioral; Buprenorphine; Chronic; Communities; Development; Disease; Distress; Dose; Drug usage; Effectiveness; Elderly; Family; Family member; Feedback; Focus Groups; Formulation; Future; HIV; HIV risk; Health; Home; Incentives; Inpatients; Intervention; Modeling; Modification; Monitor; Naltrexone; Opioid; Outcome; Overdose; Participant; Patient Self-Report; Pharmaceutical Preparations; Phase; Population; Preparation; Public Health; Randomized; Randomized Controlled Trials; Recovery; Relapse; Risk Behaviors; Schizophrenia; Self Efficacy; Series; Site; Special Population; Testing; Text; Text Messaging; Time; Training; Urine; Vulnerable Populations; Work; Youth; barrier to care; base; contingency management; criminal behavior; disorder later incidence prevention; economic evaluation; efficacy testing; high risk; high risk population; improved; innovation; intervention refinement; knowledge base; medication compliance; opioid epidemic; opioid use; opioid use disorder; outreach; prescription opioid; prevent; primary outcome; psychiatric symptom; relative effectiveness; secondary outcome; social media; substance use; treatment as usual; treatment center; treatment planning; treatment program; young adult

Project Summary/Abstract: Young people are disproportionately affected by the current opioid crisis including worse retention and outcomes compared to older adults. Further, young adults typically do not have access to medications for opioid use disorder (OUD), and for those that do, struggles with adherence are a major barrier. Standard approaches to treatment typically do not incorporate developmentally informed strategies for engagement, retention, and medication adherence for this special population. The Youth Opioid Recovery Support (YORS) model is an innovative wrap-around approach that attempts to address barriers to treatment engagement in this vulnerable young adult population, especially difficulties with medication adherence. Its components include: (1) Home delivery of extended release naltrexone (XR- NTX) for OUD; (2) Engagement of families in collaborative treatment planning and monitoring focusing on medication adherence; (3) Assertive outreach from the treatment team including actively tracking and communicating with youth and families by text messaging and social media to promote engagement and adherence; and (4) Contingency management to provide incentives for medication adherence. YORS is currently showing very promising results in a small pilot RCT by the investigative team. We propose to refine and then conduct a more definitive test of the YORS intervention for youth with OUD using the R61/R33 mechanism. In the R61 phase we will conduct stakeholder focus groups to get input and feedback on potential refinements, while also conducting 3 cycles of pilot testing of these potential refinements. Based on the R61 preparation and final synthesis of the intervention refinements, in the R33 phase we will conduct an RCT to test the efficacy of YORS, by randomizing N=120 young adults ages 18-26 seeking treatment for OUD with XR-NTX at Mountain Manor Treatment Center (MMTC), to either the refined YORS intervention or treatment as usual (TAU) for a 6-month course of treatment with XR-NTX. The primary outcome will be number of XR-NTX doses received. Secondary outcomes will include opioid relapse, days of opioid use, time to first opioid relapse, HIV risk behaviors, criminal behaviors, psychiatric symptoms, and family member distress and self-efficacy. It is hypothesized that participants in the YORS condition will receive significantly more XR-NTX doses and will demonstrate less severe opioid use and associated behaviors compared to those in the TAU group. The assertive YORS intervention has the potential to improve the real-world effectiveness and public health impact of medication for OUD in this very high-risk, vulnerable population. If the refined YORS intervention is found to be efficacious, it would set the stage for future work including: an economic analysis, a larger multi-site study, longer intervention duration, study of extended release buprenorphine, and study of step-down to less intensive interventions.

项目概要/摘要： 年轻人受到当前阿片类药物危机的不成比例的影响，包括更差的保留和 与老年人相比。此外，年轻人通常无法获得药物， 阿片类药物使用障碍（OUD），对于那些这样做的人来说，坚持斗争是一个主要障碍。标准 治疗方法通常不包括用于参与的发育知情策略， 保持和药物依从性。 青年阿片类药物恢复支持（YORS）模式是一种创新的综合方法， 解决这一脆弱的年轻成人群体接受治疗的障碍，特别是 药物依从性。其组分包括：（1）缓释纳洛酮（XR-1）的家庭递送。 （2）家庭参与协作治疗计划和监测，重点是 药物依从性;（3）治疗团队的积极外展，包括积极跟踪和 通过短信和社交媒体与青年和家庭沟通，促进参与， 依从性;和（4）应急管理，为药物依从性提供激励。YORS是 目前在调查小组的一项小型试点RCT中显示出非常有希望的结果。 我们建议完善并对青年OUD患者的YORS干预进行更明确的测试 使用R61/R33机制。在R61阶段，我们将组织利益相关者焦点小组，以获得投入， 对潜在的改进进行反馈，同时对这些潜在的改进进行3个周期的试点测试。 基于R61的制备和干预改进的最终合成，在R33阶段， 进行随机对照试验，通过随机选择120名18-26岁的年轻人， 在Mountain Manor Treatment Center（MMTC）使用XR-NTX治疗OUD， 干预或常规治疗（TAU），用XR-NTX治疗6个月。 主要结局将是接受的XR-NTX剂量数量。次要结局将包括阿片类药物 复发，阿片类药物使用天数，至首次阿片类药物复发的时间，HIV风险行为，犯罪行为，精神病 症状、家庭成员痛苦和自我效能。据推测，参与YORS的参与者 条件将接受显着更多的XR-NTX剂量，并将表现出不太严重的阿片类药物使用， 与TAU组相比，相关行为。自信的YORS干预有可能 为了提高在这种非常高风险的情况下治疗OUD的药物的真实有效性和公共卫生影响， 弱势群体。如果发现改进后的YORS干预措施有效， 未来的工作包括：经济分析，更大规模的多地点研究，更长的干预时间， 缓释丁丙诺啡，并研究逐步降低到较低强度的干预措施。